Recruiting

iVATS & VATS

Sponsor:

Brigham and Women's Hospital

Code:

NCT03623958

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Image guided Video-Assisted Thoracic Surgery (VATS) resection

Video-Assisted Thoracic Surgery

Study Details

Brief summary:

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

Conditions

Lung Cancer

Study ID

NCT03623958

Start date

Sep 11, 2018

Status verified date

Nov, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject must be 18 years and older
  • Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon
  • Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm
  • Subject's lesions that are located in the outer half portion of the lung/lobe.
  • Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics

Exclusion Criteria:

  • If participant is a pregnant woman or breast feeding they will not be eligible.
  • If treating thoracic surgeon deems the participant not eligible for the study.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iVATS resection

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

active comparator: Standard VATS resection

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Interventions

Image guided Video-Assisted Thoracic Surgery (VATS) resection

Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed

Video-Assisted Thoracic Surgery

Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Primary outcome measure

  • Operating Room Time [ Time Frame: 3 years to complete ]

Central Contacts and Locations

Central contacts

Julianne S Barlow

617-525-8704jbarlow1@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Raphael Bueno, MD

617-732-5004rbueno@bwh.harvard.edu

Julianne Barlow

617-525-8704jbarlow1@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • image guided
  • lung nodule
  • lung cancer
  • lung mass

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-11-13.